CAP 15189 Accreditation Process

The laboratory completes the online application, includes requested documentation, and submits it to the CAP.  After receiving the application, the CAP assigns a dedicated lead assessor who guides the laboratory through the subsequent steps to earn accreditation to ISO 15189.

The CAP lead assessor conducts an off-site review of the documents submitted by the laboratory. The purpose is to learn your QMS, look for major issues with the documentation, and evaluate the laboratory’s readiness for the accreditation assessment. Based on this review, the lead assessor may recommend CAP online courses, such as Internal Auditing and Root Cause Analysis.

The laboratory performs at least one internal audit of its QMS against the ISO 15189 standard. This must be done prior to the on-site accreditation assessment.

The CAP assessment team performs a detailed on-site assessment of the QMS and technical competency. This helps the laboratory identify gaps in the system and scope of work required for accreditation. The lead assessor discusses readiness for the accreditation assessment.

The laboratory updates QMS gaps as needed, including development or revision of policies and procedures and redesign of processes.

The CAP performs a detailed review of the laboratory’s QMS and technical competency. The output of the assessment is a report on the level of conformance, listing specific nonconformances, strengths, opportunities for improvement, and any vulnerabilities.

The laboratory performs root cause analysis on all nonconformances and submits corrective action responses to the CAP. The CAP reviews these responses, evaluating the root cause analysis conducted for each. Subsequently, the assessors make a recommendation to the CAP 15189 Accreditation Committee.

The CAP 15189 Accreditation Committee, which is comprised of pathologists and quality experts, reviews the assessors’ report, documentation, and corrective action reports prior to voting on whether or not to grant accreditation.

The CAP performs a review of the laboratory’s QMS focusing on ISO 15189 Section 4, Management Requirements. Progress on corrective action from prior assessments will be reviewed.

The CAP performs a review of the laboratory’s QMS focusing on ISO 15189 Section 5, Technical Requirements. Progress on corrective action from prior assessments will be reviewed.

Given the changes to data protection laws since 2012, the updated standard has honed the requirements surrounding information management. This edition features an expanded focus on laboratory information management systems (LIMS), impartiality, confidentiality, and data protection, as well as contingency planning. Laboratories will need to demonstrate procedures for the how, when, and why any information will be stored or released. There are also specific requirements around patient well-being, safety, and rights relating to their data.

There is no longer a requirement for a quality manual nor a quality manager. In addition, there are other modifications related to requirements for request forms, sample labels, and quality control.

Quality manual. While ISO 15189:2022 doesn’t require a quality manual, it remains a requirement for CAP 15189 participation to ensure alignment across CAP accreditation programs.

Quality manager. There is no longer a requirement for a “quality manager.” The quality management system features more flexibility in the structure and design as defined by the organization. For CAP 15189, ISO 15189 must be used in the design of the quality management system. If currently adhering to ISO 9001:2015, it is accepted that ISO 9001 covers many, though not necessarily all, of the quality requirements of ISO 15189. Participants will need to meet the requirements of ISO 15189 prior to CAP 15189 accreditation.

Request forms. The revised standard recognizes that the request can be in any format, agreed by both the laboratory and user.

While not required by ISO 15189 2022, the following procedures are still required for CAP 15189:

• Equipment Requirement and Reagents and Consumables (clauses 6.4.2, 6.6.1)
• Internal audits (clause 8.8.3)
• Management review (clause 8.9)
• Document control (clause 8.3)
• Resolution of complaints (clause 7.7)
• Nonconforming Work (clause 7.5)
• Risk Management, Opportunities for Improvement, and Corrective Action (clauses 5.6, 8.5 and 8.7)

Point-of-care is not in the scope of CAP 15189 accreditation, as it is included in the CAP Accreditation Checklist requirements. These checklists are developed by pathologists and laboratory experts and are a foundation of the CAP accreditation process. As the checklists are updated annually, laboratories stay current with rapidly evolving advances in point-of-care testing and all other areas of laboratory medicine, technology, and regulatory compliance.